Following today’s national holiday, both Houses of Congress are on State / District work breaks until next week.
Today’s blog is focused on preventive care topics.
HR Advisor discusses the Dos and Don’ts of Employee Wellness Programs. The FEHBlog dearly wishes that OPM would create a connection between the federal agency employee wellness and assistance programs and its FEHB plans. Doing so would help employees better navigate federal employee benefits.
NPR Shots offers encouraging news on a new initiative:
The 988 Suicide and Crisis Lifeline received over 1.7 million calls, texts and chats in its first five months. That’s nearly half a million more than the old 10-digit Suicide Prevention Lifeline fielded during the same period the year before. Launched in mid-July last year, the 988 number is modeled on the 911 system and is designed to be a memorable and quick number that connects people who are suicidal or in any other mental health crisis to a trained mental health professional. Not only are more people reaching out, more are being connected to help. Federal data shows that the Lifeline responded to 154,585 more contacts – including calls, text messages and chats – in November 2022 than the same month the year before. The number of abandoned calls fell from 18% in November 2021 to 12% last November.
The American Medical Association tells us what doctors want their patients to know about preventing cervical cancer. The upshot is HPV vaccines and HPV and pap smear testing. The article discusses topics such as the timing of testing and may be worth sharing with plan members
Speaking of vaccinations, Precision Vaccination informs us
Women can give their babies protection against whooping cough (pertussis) before their little ones are even born, says the U.S. Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration (FDA) recently approved a second, safe vaccine that prevents whooping cough from achieving that goal.
When these (Tdap) vaccines are given during pregnancy, it increases antibodies in the mother, which are transferred to the developing fetus.
On January 10, 2023, the FDA announced the Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed) is now approved for immunization during the third trimester of pregnancy.
As well as an active booster immunization against tetanus, diphtheria, and pertussis for use in persons 10 through 64 years of age.
Kaiser Family News explores when pregnant women with severe nausea should seek medical care. The FEHBlog expects this is why NCQA and OPM encourage a visit to the OB-GYN in the first trimester.
A Govexec contributor offers a simple exercise regimen for office workers.
From Capitol Hill, the Wall Street Journal reports
House Republicans passed a rules package Monday dictating the terms of the next session of Congress, the first test for House Speaker Kevin McCarthy (R., Calif.) in keeping his raucous conference united.
The rules package, a required step before moving on to legislation, is typically passed on the first day of a new Congress. But it was delayed by the GOP fight to elect a new speaker. Mr. McCarthy prevailed early Saturday morning on the 15th ballot over four days, after making a series of concessions to holdouts.
The package passed 220 to 213, with all Democrats and one Republican, Rep. Tony Gonzales of Texas, opposing the measure. It is customary for the minority party to oppose the legislation.
The package, which includes standard rules on decorum, also restores what is known as the motion to vacate the chair, a procedure that would allow one Republican member to ask for a vote to remove the speaker. It also outlines several Republican priorities around spending, such as banning consideration of any bill that has the net effect of increasing mandatory spending.
House Republican leaders chose Rep. Jason Smith (R., Mo.) to run the House Ways and Means Committee, giving him a prime perch to shape the party’s approach to tax, trade and health policy.
As chairman, Mr. Smith will lead a committee with broad power over economic policy and healthcare that is poised to receive an influx of new Republican members.
From the other side of Capitol Hill, Healthcare Dive informs us
Longtime Congressman Sen. Bernie Sanders, I-Vt., is expected next month to take the helm of the Senate’s Health, Education, Labor and Pensions Committee, bringing the Medicare-for-All proponent center stage in one of the nation’s most broadly influential health policy forums.
The anticipated appointment comes after the current committee chair Sen. Patty Murray, D-Wash., announced that she was stepping down to head the Senate Committee on Appropriations. Sanders has been on the Senate’s Health, Education, Labor and Pensions Committee, or HELP, since 2007, but the chance to lead the committee will give Sanders sway on some of his most prominent healthcare policy positions.
High healthcare costs — including prescription drugs like insulin —nursing education and elder care are issues Sanders anticipates focusing on, calling the national healthcare system dysfunctional, unsustainable and disgraceful in a Jan. 1 video.
From the FEHB front —
OMB’s Office of Information and Regulatory Affairs (OIRA) posted the federal government’s fall 2022 regulatory agenda on January 4. Here are the three FEHB rulemakings:
OPM proposes to modify its FEHB enrollment regulations regarding the effective date of coverage. The regulatory changes would allow, at an employing agency’s discretion, FEHB Coverage to become effective upon a new employee’s start date if their election is received before that date. The regulatory changes would promote the recruitment of new Federal employees and align with the best practices of the private sector. Publication of the proposed rule is scheduled for March 2023.
OPM and the three other No Surprises Act regulators plan to release a proposed rule on the law’s complicated good faith estimate and advance explanation of benefits provisions in August 2023.
As previously noted in the FEHBlog, OPM has passed along its interim final rule to implement the Postal Service Health Benefits Program to OIRA for final regulatory review. The statutory deadline for promulgating the rule is April 6, 2023. OPM clearly will meet that deadline.
Here is the complete list of OPM rule-makings in process or recently completed.
The Government Accountability Office released a report titled “Federal Employees Health Benefits Program: Additional Monitoring Mechanisms and Fraud Risk Assessment Needed to Better Ensure Member Eligibility.” The report summary tells us
More than 8 million federal employees and their families receive health insurance benefits under the Federal Employees Health Benefits program.
In 2021, the Office of Personnel Management began requiring some new program enrollees to verify that their family members are eligible. But OPM doesn’t have a process to identify and remove ineligible family members who are already enrolled in the program. As a result, the program may be spending almost $1 billion per year on payments for ineligible members.
We recommended that OPM take steps to remove ineligible family members and assess fraud risks associated with ineligible program members.
In the middle of the last decade, OPM added an FEHB contract provision requiring carriers to share OPM’s expenses to arrange for a family member eligibility audit, which is a common practice among employers. This struck the FEHBlog as a proven approach to identifying ineligible family members. Why not give it a go?
The Centers for Medicare and Medicaid Services released updated guidance for its Section 111 reporting program, which applies to FEHB carriers and other employer-sponsored health plans.
In contrast to previous recommendations, pediatricians and other pediatric healthcare providers are advised to provide “immediate, intensive obesity treatment to each patient” as soon as they receive a diagnosis, according to new guidance from the American Academy of Pediatrics (AAP).
The guidance, published in Pediatrics, marks the AAP’s first clinical practice guideline outlining evidence-based evaluation and treatment for children and adolescents with overweight (defined as a body mass index [BMI] at or above the 85th percentile and below the 95th percentile) or obesity (defined as a BMI at or above the 95th percentile), though the organization previously published recommendations on prevention and treatment in 2007.
“This is one of the most important messages that differentiates our current clinical practice guidelines from the prior recommendations, and that is to say 15 years of data have taught us that ‘watchful waiting’ only leads to greater increase in child BMI, accumulation of comorbidities, and more challenges in trying to reverse some of this,” author Sarah Armstrong, MD, co-director of the Duke Center for Childhood Obesity Research in Durham, North Carolina, told MedPage Today.
In a number of key action statements, the guideline authors state that pediatricians and other providers should refer children ages 6 years and older — and potentially those ages 2 to 5 years — with overweight or obesity to intensive health behavior and lifestyle treatment.
Additionally, healthcare providers should offer weight-loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment to adolescents ages 12 and older, Armstrong and colleagues noted. They should also offer referrals for evaluation for metabolic and bariatric surgery to adolescents ages 13 and older with severe obesity (BMI ≥35 or 120% of the 95th percentile for age and sex, whichever is lower).
This flu season hit earlier and harder than those of the past couple of years, doctors say. The reason is likely because of the cyclical nature of the flu and the lifting of Covid precautions such as working from home, wearing masks and having smaller social gatherings, says Robert Frenck, a pediatrician in the division of infectious diseases at Cincinnati Children’s hospital in Ohio.
We asked doctors what to expect this year if the influenza virus causes illness in your household.
Doctors are frustrated that patients are getting test results before they can explain them, POLITICO’s Ben Leonard reports.
A recently implemented federal [information blocking] rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share.
The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth?
Before this rule was in effect, a member of the FEHBlog’s family received an email on a Sunday morning suggesting that she log into the patient portal. She promptly did so and was faced with confusing test results. See Seinfeld. Can’t doctors give patients a choice at the time of portal registration to get the log on email or wait to hear the results from a medical professional in non-emergency circumstances?
Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts.
The timing was not offered, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 shot. The Moderna pricing was first reported by The Wall Street Journal and confirmed by a company spokesperson.
The 41st JP Morgan healthcare conference is being held this week in San Francisco. “Fierce Healthcare will be covering the day’s biggest news as it happens. Check back here for updates, and catch Fierce Biotech’s reporting here and Fierce Pharma’s reporting here.”
The Senate is on a State work break until January 23.
The House of Representatives will be in session this week for floor business. The Wall Street Journal adds
The House will dive into its first week of substantive work with bills to cut Internal Revenue Service funding and investigate economic competition from China, after a leadership election that underscored Republican divides and the fragile position of Speaker Kevin McCarthy (R., Calif.). * * *
On Monday, the House will vote on a set of chamber rules for the 118th Congress that will enshrine some of the pledges regarding legislative procedure Mr. McCarthy made to win over holdouts in his speaker election. The rules package will also make key changes to the operations of the Office of Congressional Ethics, which conducts initial reviews of allegations of impropriety against lawmakers.
“We’ll pass the rules package tomorrow, and we’ll get moving on doing what the American people elected us to do,” said Rep. Jim Jordan (R., Ohio), the incoming Judiciary Committee chairman and a prominent McCarthy ally, in an interview Sunday on Fox News. “In a two-year time span, we have seen a border that is no longer a border. We have seen a military that can’t meet its recruitment goals. We’ve seen terrible energy policy, terrible education policy…We’re going to unite around fixing those problems.”
Democrats said they hoped to find areas of bipartisan agreement. “Clearly we are going to have strong disagreements at times, but we can agree to disagree without being disagreeable,” said House Minority Leader Hakeem Jeffries (D., N.Y.) on NBC on Sunday.
The Journal also provides greater insight into the availability of the new Alzheimer’s disease drug that the FDA approved last week.
A sweeping Medicare rule issued last year [following the Aduhlem fiasco] will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come.
The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab,for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned.
The Alzheimer’s Association patient-advocacy group asked the Centers for Medicare and Medicaid Services in December to reconsider its policy, a process that could take as long as six to nine months if it chooses to do so.
As many as 85% of patients who could benefit from Leqembi are insured by Medicare, said Ivan Cheung, Eisai’s global Alzheimer’s disease officer. Eisai projects that 100,000 patients could be using the drug by its third year on the market, assuming that Medicare officials lift coverage restrictions, Mr. Cheung said.
From the public health front, Forbes delves into Omicron XBB 1.5. As the FEHBlog noted last Friday new Covid cases and hospitalizations are up because winter has arrived. Forbes reminds us
From Dec. 21 to 27, 2022, 5,613 people were admitted with positive COVID tests, compared to 6,519 from Dec. 28 to Jan. 3. However this is still a far cry, down 69.7%, from the peak seven-day average in mid-January 2022 when 21,525 were admitted with COVID.
Last year’s Omicron alpha phase dwarfs the current surge which the FEHBlog attributes to the fact that Paxlovid did not reach the market until December 22, 2021.
Forbes also offers parents information about signs and symptoms of invasive strep cases currently afflicting children.
NPR Shots reports on the worthy efforts of various physicians to improve the care of miscarrying patients.
“Fewer abortions will mean more pregnancies, and more pregnancies will mean more miscarriages,” said Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Washington and a co-author of the guidelines on miscarriage management for the American College of Obstetricians and Gynecologists.
Around 15% of known pregnancies end in miscarriage, and the first medical professional many of those patients see will be in an emergency room. Yet, by and large, she says, “emergency medicine physicians aren’t trained in managing miscarriage and don’t see it as something they should own.”
For more than a decade, Prager has been trying to change that through her work with the TEAMM Project, the nonprofit she co-founded on the premise that “many people experience miscarriage before they’re established with an OB-GYN.” Short for Training, Education and Advocacy in Miscarriage Management, TEAMM has conducted in-person workshops for clinicians at more than 100 sites in 19 states on all aspects of miscarriage care — everything from the use of ultrasound to diagnose fetal death to the three treatment options miscarrying patients should be offered when they come in for care.
From the medical trial front, the Wall Street Journal points out a significant issue with cancer treatment trials.
After Mikhail Rubin learned his lethal blood disease had progressed, he decided that he wanted a stem-cell transplant through a clinical trial. But there was an obstacle: his age.
Mr. Rubin, who is now 72, was too old to participate. Many cancer trials cap enrollment at age 65. Even when trials for older people are available, oncologists are reluctant to enroll elderly patients because frailties might make them less resilient against side effects from toxic treatments, according to a 2020 study in an American Cancer Society journal. People over 70 represent a growing share of the cancer-patient population but are vastly underrepresentedin clinical trials, the study said.
“How can we make decisions for people over 70 if people over 70 are not included in the trials that we use to base our decision making?” said Dr. Mina Sedrak, deputy director of the Center for Cancer and Aging at City of Hope, a cancer center near Los Angeles and an author of the paper.
Fair question, Dr. Sendrak.
From the health plan consumer app front, Fierce Healthcare tells us
Elevance Health is making the latest expansion to its Sydney member app with the addition of a new Nutrition Tracker tool.
The tracker uses artificial intelligence to recognize foods in photographs taken by a member’s smartphone camera. It can log individual foods as well as entire meals using this functionality, the insurer, formerly Anthem, said.
Once the information on a meal is logged, it can quickly be added to the member’s health record and then be shared with their provider, with consent, allowing for personalized feedback from their medical team.
Anil Bhatt, global chief information officer at Elevance Health, told Fierce Healthcare that the insurer wants Sydney to be able to offer as much valuable information to the member “at their fingertips” as possible. Elevance Health regularly gathers consumer feedback on features that would most benefit them.
Finally the FEHBlog noticed that NPR Shots is offering useful advice for white collar workers.
After staring at a computer screen for hours at a time, the body often gives us a clue that it is stressed: nagging neck and back pain.
To fix the problem, you might have gotten advice to focus on posture or ergonomics, but exercise research points to another strategy as well – taking short spurts of movement throughout the day to release tension and stress in the body.
“As a society, the assumption is that we have pain because of poor posture and slouching,” says Kieran O’Sullivan, an associate professor of physiotherapy at the University of Limerick’s School of Allied Health in Ireland. “But [the issue] isn’t as neat and tidy as we thought. We have been trying all these fixes [with ergonomics] and it has arguably not fixed the problem. I think it is more about needing breaks from the working day with … movement.”
Here’s how researchers think quick hits of movement – sometimes called exercise “snacks” – may help prevent pain. When the brain senses physical or emotional stress, the body releases hormones that trigger muscles to become guarded and tight. Exercise counters that stress response by increasing blood flow to muscles, tendons and ligaments and sending nutrients to the spine’s joints and discs.
From Capitol Hill, the Wall Street Journal reports
Rep. Kevin McCarthy stepped up negotiations with Republican detractors, offering fresh concessions to win support after a third day of House speaker votes yielded no movement toward a winner in the GOP-controlled chamber.
Mr. McCarthy and some of his detractors appeared to be coalescing around a deal, stepping up the pace of discussions as the House marked its 11th round of votes with no winner, the most since just before the Civil War. While most Republicans backed Mr. McCarthy over three days of tallies, 20 continued to oppose him, and it wasn’t known if enough detractors would potentially change their votes to give Mr. McCarthy the gavel. All Democrats supported their pick, Rep. Hakeem Jeffries of New York.
Shortly after 8 p.m., lawmakers voted 219-213 to adjourn until Friday at noon, with Republicans in favor and Democrats opposed.
Voting is expected to continue into the weekend.
From the Affordable Care Act front, the FEHBlog discovered today that on December 12, 2022, the Department of Health and Human Services announced the maximum 2024 out-of-pocket limits for in-network care offered by FEHB and other group health plans.
[T]he 2024 maximum annual limitation on cost sharing is $9,450 for self-only coverage and $18,900 for other than self-only coverage. This represents an approximately 3.8 percent increase above the 2023 parameters of $9,100 for self-only coverage and $18,200 for other than self-only coverage.
The announcement also covers other ACA topics: the premium adjustment percentage, reduced maximum annual limitation on cost sharing, and required contribution percentage, which apply to marketplace plans.
From the New Year front —
Mercer offers strategic planning guidance for health plan and human resources executives.
STAT News identifies three drug pricing issues to watch this year — 1. Inflation Reduction Act implementation; 2. Medicare’s lecanemab coverage decision, and 3. Insulin cost protections.
Tammy Flanagan writes in Govexec about Federal “Employee Benefit Changes for 2023; How new pay rates, Social Security earnings limits and other factors could affect your retirement planning.”
Bloomberg Prognosis offers a January guide to weight loss.
Healio adds, “More physical activity was associated with a lower risk for type 2 diabetes regardless of age, sex, BMI or sedentary time, according to an analysis published in The Journal of Clinical Endocrinology & Metabolism.”
Teladoc Health announced on Thursday it’s launching a new app allowing users to access its full range of services in one place and under one account.
The app, which includes primary care, mental health and chronic condition management, is meant to integrate all of Teladoc’s assets in one personalized platform, making care navigation and selection easier for consumers,
Teladoc Chief Medical Officer Vidya Raman-Tangella told Healthcare Dive. The app is available to a select number of Teladoc’s existing clients this month. Teladoc plans to make the app available to the full market later this year.
Fierce Healthcare adds “Teladoc’s full suite of services will be available in the Spanish language on the mobile app and the website, marking a critical shift with more than 40 million people in the United States reporting they speak Spanish at home.”
CMS announced adding “a new telehealth indicator on clinician profile pages on Medicare Care Compare and in the Provider Data Catalog (PDC). The new indicator helps beneficiaries and caregivers more easily find clinicians who provide telehealth services.”
Two of the biggest pharmacy chains in the country are planning to seek the certification needed to dispense abortion pills in the states where it is legal, according to spokespeople for the companies.
The decisions by Walgreens and CVS are likely to provide a boost to a new Food and Drug Administration (FDA) policy announced Tuesday that will allow retail pharmacies to dispense mifepristone from a certified prescriber if they meet certain criteria.
Until 2021, mifepristone could only be dispensed in person by a physician. The FDA temporarily lifted that requirement because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.
A bloc of [twenty] Republican opponents Tuesday kept Kevin McCarthy from becoming speaker on three ballots, and the House adjourned to come back on Wednesday and try again to pick a leader.
McCarthy, R-Calif., had told his colleagues as the day began he would not back down, and his supporters said there would be repeated votes. After three votes, the last of which saw McCarthy lose one of his earlier supporters, a motion from McCarthy ally Tom Cole of Oklahoma to adjourn until noon Wednesday was adopted by voice vote.
The history-making chaos in the House drew most of the attention Tuesday, but longtime senators were making history of their own.
Sen. Patty Murray, D-Wash., was elected as the first woman to serve in the constitutional office of president pro tempore, while Senate Minority Leader Mitch McConnell eclipsed Montana Democratic Sen. Mike Mansfield’s record for length of service as a party floor leader. * * *
And not to be outdone, [Sen. Chuck] Schumer had some history of his own, becoming the longest serving senator from the state of New York.
The nation’s health agencies already have a long to-do list for 2023.
Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. Biden administration appointees are racing to fix pandemic-exposed cracks in the systems for mental health care, addiction treatment, and health coverage, even as millions of people are likely to be kicked out of Medicaid, the federal program serving low-income people with few resources. There’s still no one leading the National Institutes of Health.
And while Congress delivered many of the president’s requests in the end-of-year spending package last month, it also dropped several provisions that would have given federal health regulators more authority.
From the New Years predictions front, STAT News informs us
For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth.
From the pricing transparency front, Kaiser Health News reminds us that
As of Jan. 1, health insurers and employers that offer health plans [including FEHB plans] must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs. * * *
So how will it work?
Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.
Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.
Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.
Starting in 2024, the requirement on insurers expands to include all drugs and services.
This requirement was created by the 2020 Transparency in Coverage Rule issued under the 21st Century Cures Act and the 2021 No Surprises Act.
According to the recent report by the OIG investigating instances of incorrect co-surgery and assistant-at-surgery modifier usage, 69 of 100 sampled procedural services did not meet federal requirements.
An additional review of 127 corresponding services found that 49% were noncompliant with federal requirements, as well.
The OIG reviewed a randomly selected sample of 100 services rendered by Part B providers between 2017 and 2019 with certain CPT procedural codes and a Medicare Physician Fee Schedule (MPFS) co-surgery indicator of 1 or 2. The reviewed procedures included spinal fusions, knee replacements, and endovascular repairs, among others.
That’s a big bowl of wrong.
From the pricing reforms front, Fierce Healthcare relates
Physician group practices participating in the Bundled Payments for Care Improvement (BPCI) Initiative garnered cost savings for the top five conditions that require medical intervention but did not save money for the top five surgical procedures.
On the other hand, hospitals participating in the BPCI initiative saved money for both categories, according to a study in JAMA Health Forum.
Researchers at the University of Pennsylvania said their findings underscore the “suitability of hospitals to bundled payment models, specifically highlighting their relative advantage over group practices in achieving cost and potential quality outcomes for medical conditions.”
From the Rx coverage front —
Biopharma Dive offers us a look back at the FDA’s drug approvals in 2022 — “The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.” — and a look forward at ten clinical trials to watch in the first half of 2023 — “Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.”
STAT News has questions stemming from the recent Congressional investigative report on the Aduhelm fiasco.
The New York Times reports “For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication. * * * Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said: “We are going to review the F.D.A.’s decision.”
The Wall Street Journal adds “Most abortions in the U.S. happen via the pill, according to the Guttmacher Institute. Several organizations that mail abortion pills, sometimes to women in states with abortion bans, have seen shipments increase since the Supreme Court’s latest abortion decision. * * * Also on Tuesday, the Justice Department issued an opinion saying that abortion pills can be sent through the U.S. mail, as long as the sender doesn’t intend them to be used unlawfully. The U.S. Postal Service and the Department of Health and Human Services had asked the Justice Department to clarify an 1873 law, which had been invoked by Mississippi’s attorney general in a lawsuit last year, that prohibits mailing items that can be used to produce abortions.”
From the mental healthcare front, the American Hospital Association places a spotlight on children and adolescent care.
NPR shares its favorite articles with “actionable, evidence-based strategies for cultivating a healthy body and mind.”
Fortune Well identifies “six foods and drinks to choose in the New Year to improve mood, energy, and longevity” and discusses the differences between dry January and damp January.
The American Medical Associations tells us about what doctors wish their patients knew about effective New Years resolutions.
From Capitol Hill, the Wall Street Journal reports
A new era of divided government dawns this week as the 118th Congress begins, with Republicans looking to deploy their power with a fragile majority in the House and Democrats doing the same in the Senate.
The House of Representatives will convene on Tuesday, a date designated by the 20th Amendment of the U.S. Constitution that stipulates Congress should begin each new session at noon on Jan. 3.
The first order of business will be electing a new Speaker. The last time that the election went beyond one ballot was one hundred years ago, but the streak could be broken tomorrow as Roll Call explains.
The Senate whose leadership is not changing will hold a routine opening day tomorrow.
No Congressional Committee hearings will be held this week.
From the Omicron and siblings front, NBC News and Forbes each offer detailed looks at the latest dominant Omicron variant XBB and XBB 1.5. NBC News states
“It’s clear that there’s immune evasive properties of XBB,” said Dr. Isaach Bogoch, an infectious disease physician and epidemiologist at the University of Toronto. “That’s been demonstrated both in laboratory studies and seen clinically in cases and hospitalizations.”
Given the high level of population immunity in the U.S. — either through infection, vaccination or both — Bogoch and others hope that, even if cases start to rise significantly, there won’t be a dramatic spike in hospitalizations or deaths as seen in previous waves.
Antibody studies don’t tell the whole story. Other parts of the immune system can protect against the virus and the Covid vaccines should remain effective at preventing severe illness and death from the virus, evidence suggests.
From the FEHB front, the Postal Service’s Inspector General released a “primer” on the 2022 Postal Reform Act, which requires a new Postal Service Health Benefits Program to be launched in two years.
From the Affordable Care Act marketplace, Health Payer Intelligence informs us
Affordable Care Act (ACA) marketplace enrollment has grown 18 percent from last year, with 11.5 million people signing up for coverage as of December 15, 2022, HHS announced.
“Unprecedented investments lead to unprecedented results. Under President Biden’s leadership, we have strengthened the Affordable Care Act Marketplace with continued record affordability, robust competition, and historic outreach efforts – and today’s enrollment numbers reflect that,” HHS Secretary Xavier Becerra said in the press release. * * *
“Thanks to the Inflation Reduction Act, four out of five customers will be able to find a plan for $10 or less. As we head into the new year, there is no greater gift than the peace of mind that comes with having high-quality, affordable health care. There is still time to sign up until January 15 – visit HealthCare.gov today,” Becerra added.
The Washington Examiner reports that “President Joe Biden signed the nearly $2 trillion omnibus spending bill into law Thursday night while vacationing in St. Croix.”
The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.
The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documentsshowed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.
The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.
STAT News also presents eight key takeaway‘s from the Congressional report on Aduhelm’s approval and reports
Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year.
Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy.
“The results from this long-awaited study are great news for hemophilia B patients that soon may have access to a second durable treatment option,” Luk Vandenberghe, a gene therapy expert at Harvard, said in a text message, after reviewing the results.
Looking toward next year, STAT News discusses “three things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs.”
Consider the already-astronomical cost of chronic disease care in the United States: trillions of dollars devoted to diabetes, heart disease, kidney disease, cancer and other conditions, and still so many people unable to access necessary care and treatments. Consider the strain of Covid on the health care system, the decimation of public health staffing, and the scarcity of health care workers — and how all these costs make their way to patients. What bold moves can be made in 2023 to help reduce the cost of care? We’ll see.
Also, from the healthcare cost front, Beckers Hospital Review looks into “Questions about hospitals’ culture, leadership, survival and opportunity come with a trillion-dollar price tag given the importance of hospitals and health systems in the $4.3 trillion U.S. healthcare industry.”
From the public health front, the Wall Street Journal reports
A measles outbreak among mostly unvaccinated children in Ohio that local health officials feared could take months to control has slowed in the past week, giving hope that what was expected to be a lengthy battle could be cut short.
The total number of cases since the outbreak began in November reached 82 on Thursday, but new cases have fallen off significantly in the last seven days or so, said Mysheika Roberts, Health Commissioner for the city of Columbus.
“It could be much worse,” Dr. Roberts said Thursday. “I’m hoping due to our outreach in the community, and the community’s willingness to roll up their sleeves and get vaccinated, that we might be starting to see the end of this. But obviously, it’ll take several weeks and days before we’ll know if this is actually over.”
Merck & Co Inc’s COVID antiviral molnupiravir speeds up recovery but does not reduce the hospitalisation or death rate in higher-risk vaccinated adults, detailed data from a large study showed on Thursday. * * *
When Merck originally tested molnupiravir, it was found 30% effective in reducing hospitalisations, but that was in unvaccinated patients.
In the latest study, led by University of Oxford researchers, nearly all of the more than 25,000 patients in the study had received at least three vaccine doses.
These results demonstrate that vaccine protection is so strong that there is no obvious benefit from the drug in terms of further reducing hospitalisation and deaths, said study co-author Jonathan Van-Tam from the University of Nottingham.
The drug was, however, effective in reducing viral load and can help hasten patient recovery by roughly four days, researchers estimated based on study data.
About 2.6 million couples are saying “I do” this year [2022] — roughly 600,000 more than in prepandemic years, according to The Knot, a company that offers wedding-planning tools, a vendor marketplace and a gift-registry platform.
The wedding boom is the byproduct of two years of the pandemic, when many ceremonies were postponed or pared down, says Lauren Kay, executive editor of The Knot. And ceremonies this year have a whole new vibe. Now, “people feel empowered to personalize, push the envelope—rules are out the window,” Mrs. Kay says. * * *
This year, “weddings are back, and people are excited to celebrate,” Mrs. Kay says. In 2023, weddings in the U.S. will likely return to prepandemic levels at 2.1 million, according to internal research from The Knot.
The Washington Post looks into “Why do people like being tipsy? Here’s how alcohol affects the brain. The buzz produced by alcohol comes from a cocktail of pharmacology and social ingredients, research shows.” The article also discusses how to enjoy alcoholic beverages responsibly.
Finally, the Department of Health and Human Services announced
a Notice of Proposed Rulemaking (NPRM), entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination. * * *
Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register.
From Capitol Hill, the National Rural Healthcare Association trumpets the “big rural health advocacy wins in FY23 appropriations bill” that the President will be signing this week. Notably —
Given the devastating outcome of COVID-19 in rural areas, NRHA has been committed to working with Capitol Hill to see an Office of Rural Health created at the Centers for Disease Control and Prevention (CDC). Included in the FY 2023 appropriations bill was $5 million to establish an Office of Rural Health at CDC. The text dictates that the ORH will enhance implementation of CDC’s rural health portfolio, coordinate efforts across CDC programs, and develop a strategic plan for rural health that maps the way forward both administratively and programmatically. This is a massive victory for rural health, and NRHA is looking forward to working with CDC to see this stood up quickly, to ensure rural representation in America’s public health infrastructure.
$3.45 billion for the Rural Community Facilities Program and $2 million for the Rural Hospital Technical Assistance Program through the United States Department of Agriculture Rural Development (RD) programs.
Omicron subvariant XBB is encroaching on BQ.1 and BQ.1.1’s dominance, CDC data shows, as it accounts for 18.3 percent of U.S. cases and makes up more than 1 in 2 infections in the Northeast.
Subvariants BQ.1 and BQ.1.1, which became the nation’s most pervasive strains in November, are on the decline.
The FDA began tracking XBB on Nov. 28. The subvariant is a fusion of two other omicron subvariants, BA.2.10.1 and BA.2.75, and it caused a wave of cases in Singapore. Eric Topol, MD, founder and director of Scripps Research Translational Institute in San Diego, wrote Dec. 23 that XBB mutation XBB.1.5 “has the most growth advantage vs. BA.5,” which was causing most COVID-19 cases for months.
Beckers also reports, “The CDC issued a health advisory on Dec. 22 to alert the medical community of a rise in severe strep A infections among children. * * * Read the full advisory and provider recommendations here.”
From the U.S. healthcare business front, the Wall Street Journal challenges non-profit hospital business practices which fail to help the needy.
Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades.
As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.
Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them. * * *
Ascension was the most active deal maker in the Journal’s review. Through deals involving 93 hospitals over the past 20 years, Ascension has grown into one of the largest U.S. systems, with $28 billion in revenue and $19.5 billion in cash reserves in its most recent fiscal year, ended June 30.
Among the hospitals Ascension pruned as it grew were those serving some of the poorest neighborhoods of Washington, D.C., and Chicago.
Local elected officials said that when a system exits a market, it can be difficult for remaining facilities to serve the community.
The Journal also questions online advertising for prescription drugs by certain telehealth companies.
In an advertisement on Facebook and Instagram, a middle-aged man holding a dumbbell says testosterone “literally changed my life,” restoring his energy and happiness.
What the October ad from telehealth startup Hone Health doesn’t say is that the unidentified man is an actor who has never used the prescription drug. It doesn’t mention that testosterone is approved by the Food and Drug Administration only for men with specific disorders and that among its risks are heart attacks and stroke.
Similar telehealth companies are flooding TikTok, Instagram and other platforms with ads that don’t conform to longtime standards governing the marketing of prescription drugs and healthcare treatments. They feature actors posing as customers, tout benefits of drugs with no mention of side effects and promote medications for uses not approved by the FDA.
In the two years since the government expanded the scope of medical services allowed via video calls, telehealth companies have been operating largely outside advertising rules that govern drugmakers, a gray area subject to little government oversight or guidance. Instead, the main gatekeepers exercising the power to review or remove telehealth advertising are the social-media giants paid to run the ads.
President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.
As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *
The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.
From the public health front —
The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”
From the Rx coverage front —
The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.
A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription.
Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.
HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year. * * *
Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.
Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *
Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.
Per Roll Call, the House of Representatives followed the Senate by passing the Consolidated Apppropriations Act 2023 and the one week further extension of the continuing resolution to December 30, 2023. The 117th Congress has completed its work.
The Centers for Disease Control will not be published its weekly interpretation of Covid statistics until next year as today and next Friday precede three day weekends.
The CDC did update its Covid data tracker and Fluview which happens on Thursdays. The new daily Covid cases and deaths for the week ending December 22 averaged approximately 69,600 cases and 420 deaths. “Seasonal influenza activity remains high but is declining in most areas.” As noted in yesterday post, RSV cases appear to have peaked.
In No Surprises Act news, the Labor Department’s Employee Benefit Administration announced this afternoon
Effective January 1, 2023, the administrative cost for holding an arbitration under an independent dispute resolution process will increase from $50 per party to $350 per party. That should tamp down the number of NSA arbitrations.
ACA FAQs 56 concerning the NSA prescription drug reporting that health plans, including FEHB plans, are scheduled to submit next Tuesday, December 27, for the 2020 and 2021 plan years. Significantly,
For the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement action with respect to any plan or issuer that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug Data Collection (RxDC) Reporting Instructions in making its submission. The Departments are also providing a submission grace period through January 31, 2023, and will not consider a plan or issuer to be out of compliance with these requirements provided that a good faith submission of 2020 and 2021 data is made on or before that date.
Initial Report on the Independent Dispute Resolution Process: April 15 – September 30, 2022.
The FEHBlog will release Cybersecurity Saturday on December 24 and the Holiday weekend update on December 26. Merry Christmas and of course Jingle Bells.
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